Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-01 @ 11:59 PM
Study NCT ID:
NCT03746535
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2018-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Disease Risk in Women With Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539351', 'term': 'elagolix'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no masking, all subjects have endometriosis'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 cohort clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow Mediated Vasodilation Microvascular skin blood flow analysis', 'timeFrame': '2 minutes', 'description': 'Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system.'}, {'measure': 'Microdialysis perfusions', 'timeFrame': '15 minutes', 'description': 'Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.', 'detailedDescription': 'Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young women between the ages of 18 and 45 years (Controls);\n* Young women between the ages of 18 and 45 years with endometriosis.\n\nExclusion Criteria:\n\n* Subjects who smoke\n* Subjects who have diabetes,\n* Subjects with sleep apnea or BP\\>140/90 will be excluded.\n* Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.'}, 'identificationModule': {'nctId': 'NCT03746535', 'briefTitle': 'Cardiovascular Disease Risk in Women With Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis', 'orgStudyIdInfo': {'id': '2000022193'}, 'secondaryIdInfos': [{'id': '1R01HL161000-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL161000-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patients without endometriosis', 'description': 'Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis', 'interventionNames': ['Drug: Elagolix']}, {'type': 'EXPERIMENTAL', 'label': 'patients with endometriosis', 'description': 'Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor.', 'interventionNames': ['Drug: Elagolix']}], 'interventions': [{'name': 'Elagolix', 'type': 'DRUG', 'description': 'Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.', 'armGroupLabels': ['patients with endometriosis', 'patients without endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nina Stachenfeld', 'role': 'CONTACT', 'email': 'nina.stachenfeld@yale.edu', 'phone': '203-530-8071'}], 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Nina Stachenfeld, PhD', 'role': 'CONTACT', 'email': 'nina.stachenfeld@yale.edu', 'phone': '203-562-9901', 'phoneExt': '219'}], 'overallOfficials': [{'name': 'Nina Stachenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}